Strict Need to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy

NCT ID: NCT05108506

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2024-04-01

Brief Summary

Patients who are undergoing non-urogynecologic, minimally invasive (laparoscopic, robotic) hysterectomy who are discharged the day of surgery will be randomized to a strict need to void versus no need to void prior to discharge.

To determine if a strict versus liberal voiding trial following the aforementioned surgery in same day discharge patients increases rates of post-operative urinary retention, urinary tract infection (UTI), or re-presentation and if there is a difference in Post-Anesthesia Care Unit (PACU) time and costs.

Conditions

Urinary Retention Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

No strict need to void following surgery before discharge

Participants randomized to this arm will have no strict need to void following surgery before they are discharged.

Group Type: EXPERIMENTAL

No Strict need to void following surgery

Intervention Type: BEHAVIORAL

Certain patient will be randomized without a strict need to void prior to discharge following surgery.

Strict need to void following surgery before discharge

Participants randomized to this arm will have a strict need to void following surgery before they are discharged.

Group Type: PLACEBO_COMPARATOR

Strict need to void following surgery

Intervention Type: BEHAVIORAL

Certain patient will be randomized with a strict need to void prior to discharge following surgery.

Interventions

No Strict need to void following surgery

Certain patient will be randomized without a strict need to void prior to discharge following surgery.

Intervention Type: BEHAVIORAL

Strict need to void following surgery

Certain patient will be randomized with a strict need to void prior to discharge following surgery.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women 18+ undergoing minimally invasive benign, non-urogynecologic hysterectomy
• English speaking

Exclusion Criteria

• At the surgeons discretion based on amount of bladder dissection the patient can be removed from the study at the conclusion of surgery
• Any patient with a history of prior urologic procedures
• Patients with any baseline known urinary disease
• Any bladder injury at the time of surgery
• Any combined cases with other surgical services
• Patients undergoing surgery for prolapse or incontinence symptoms
• Patients who are ultimately not discharged the same day and remain in house overnight

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Patzkowsky

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00307084

Identifier Type: -

Identifier Source: org_study_id